Tardyferon-fol

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Tardyferon-Fol
80 mg iron(II) ions + 0.35 mg, modified-release tablets
Ferrosi sulfas + Acidum folicum
Please read the entire leaflet carefully before using this medicine, as it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Tardyferon-Fol is and what it is used for
2. Important information before taking Tardyferon-Fol
3. How to take Tardyferon-Fol
4. Possible side effects
5. How to store Tardyferon-Fol
6. Contents of the pack and other information

1. What Tardyferon-Fol is and what it is used for

Tardyferon-Fol is a combination medicine containing ferrous sulfate and folic acid. Iron is released slowly and uniformly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The delayed release has a beneficial effect on iron absorption in the intestine. Folic acid is rapidly absorbed.
During pregnancy, the body's demand for iron increases significantly, making iron deficiency more likely. Initially, iron deficiency may cause general symptoms such as reduced appetite or rapid fatigue, without signs of anemia. Only when iron deficiency becomes substantial—that is, when there is insufficient iron for the necessary production of hemoglobin—does overt iron deficiency with anemia develop. General symptoms worsen, and additional signs such as cracking at the corners of the mouth, brittle nails, and hair may appear.
Significant folic acid deficiency may lead to disturbances in the production of red blood cells, white blood cells, and platelets—although this condition is rare.
Tardyferon-Fol is used for the prevention and treatment of iron and folic acid deficiencies in pregnant women.
Tardyferon-Fol is indicated for use in pregnant women.

2. Important information before using Tardyferon-Fol

When not to use Tardyferon-Fol:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• in all cases of anemia due to causes other than iron deficiency;
• in cases of iron accumulation (hemochromatosis, chronic hemolysis, frequent transfusions);
• in cases of impaired iron utilization (sideroachrestic anemia, lead poisoning-induced anemia, thalassemia, late cutaneous porphyria);
• in cases of confirmed iron intolerance (e.g. severe inflammatory changes in the gastrointestinal tract);
• if there are severe impairments of liver or kidney function;
• in children.

Warnings and precautions
Before starting treatment with Tardyferon-Fol, discuss it with your doctor or pharmacist.
Iron-containing preparations should be used only after consultation with a doctor, especially in cases of gastrointestinal inflammation, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Hypoferremia associated with inflammatory conditions does not respond to iron therapy. Iron treatment should, whenever possible, be combined with causal treatment.
Tardyferon-Fol must be stored out of reach of children, as even the smallest package (30 modified-release tablets) contains a total dose of iron which, if taken at once, may (especially in young children) lead to life-threatening poisoning.
Administration of folic acid during treatment with antiepileptic drugs may increase the metabolism of these drugs to normal levels after prior reduction due to deficiency, potentially decreasing their blood concentrations. Monitoring of antiepileptic drug levels is necessary and dosage adjustments may be required.
Tell your doctor before taking Tardyferon-Fol:

• if the patient has difficulty swallowing.

If the patient accidentally inhales a tablet, contact a doctor immediately, as there is a risk of bronchial ulceration or narrowing if the tablet enters the respiratory tract. This may cause persistent cough, hemoptysis, and/or shortness of breath, even if aspiration occurred several days or even months before the onset of these symptoms. Therefore, prompt evaluation is needed to rule out damage to the patient's respiratory tract by the tablet.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and who were receiving iron supplementation due to concomitant anemia.
Due to the risk of oral ulceration and tooth discoloration, tablets should not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following this instruction is not possible or if swallowing difficulties occur, contact your doctor.

Tardyferon-Fol and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Iron
Combinations not recommended:
Iron (salts) (administered by injection):
Fainting, and even shock due to rapid release of iron from its complex form and transferrin saturation with iron.
Concomitant use of certain antibiotics (tetracyclines) with Tardyferon-Fol reduces their effectiveness.
Iron absorption from Tardyferon-Fol is reduced when administered simultaneously with:

• magnesium, phosphate, calcium, or gold salts;
• if the patient is taking cholestyramine, Tardyferon-Fol should be taken 1 to 2 hours before or 4 to 6 hours after cholestyramine;
• with drugs that neutralize gastric acid (containing aluminum, magnesium trisilicate, calcium – these should be taken at least 2 hours after administration of the iron-containing medicine);
• with calcium and zinc (these should be taken at least 2 hours after administration of the iron-containing medicine).
  Concomitant administration of chloramphenicol may delay the therapeutic effect of iron and its compounds.

During treatment with iron preparations, absorption of bisphosphonates, fluoroquinolones, methyldopa, levodopa and carbidopa, thyroxine, D-penicillamine, and zinc compounds is reduced (these should be taken at least 2 hours after administration of the iron-containing medicine).
The gastric and intestinal mucosa-irritating effect of iron-containing medicines may be intensified by concomitant use of certain non-steroidal anti-inflammatory drugs (NSAIDs) (salicylates, phenylbutazone, oxyphenbutazone). These medicines should be taken at least 3–4 hours after taking the iron-containing medicine.

Due to the presence of folic acid in Tardyferon-Fol, concomitant use with other medicines also requires special precautions.
Sulfonamides, sulfasalazine, methotrexate, antiepileptic drugs (such as phenobarbital, phenytoin, primidone, fosphenytoin), and sedatives negatively affect folic acid absorption.
Inform your doctor about all medicines you have recently taken, even those available without a prescription.

Tardyferon-Fol with food, drink, and alcohol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption. Concomitant use of this medicine with whole-grain products (bran, legumes, oilseeds), certain proteins (eggs), or foods and drinks containing calcium (cheese, milk, etc.) is not recommended. An interval of at least 2 hours should be maintained between taking iron salts and consuming these products.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should only be administered if the expected therapeutic benefits outweigh any potential risks to the fetus.
The amount of iron and folic acid from Tardyferon-Fol that passes into breast milk has not been established, and it is unknown whether adverse effects may occur in infants breastfed by mothers receiving this treatment.
During pregnancy and breastfeeding, Tardyferon-Fol should be taken only on a doctor's prescription (see section 1, "What Tardyferon-Fol is and what it is used for").

Driving and operating machinery
It is unlikely that Tardyferon-Fol has any influence on the ability to drive or operate machinery.

3. How to use Tardyferon-Fol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of ferrous ions(II) and 0.35 mg folic acid, daily or
on alternate days during the last two trimesters of pregnancy (or from the 4th month of pregnancy).
Tardyferon-Fol tablets are intended for oral administration.
The tablets should be taken with a large glass of water, before or during meals, depending on gastrointestinal tolerance (however, you should avoid the food and drink products listed in the section “Tardyferon-Fol with food, drink and alcohol”).
The tablet should be swallowed whole with water. Do not suck, chew or hold the tablet in the mouth.

Taking more Tardyferon-Fol than recommended
Cases of iron salt overdose, particularly in children, have been reported following ingestion of a large amount of the medicine.
Symptoms of overdose include signs of gastrointestinal irritation with accompanying abdominal pain, nausea, vomiting, diarrhoea, cardiovascular shock symptoms or metabolic acidosis (rapid or shallow breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
If you have taken too much of the medicine, contact the emergency department immediately for appropriate treatment.

Missing a dose of Tardyferon-Fol
If you miss a dose at your usual time, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose and take the next tablet at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Tardyferon-Fol
Tardyferon-Fol should be taken for as long as your doctor recommends. Premature discontinuation of treatment may result in recurrence of the condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The reactions are listed below in decreasing order of frequency.
Common (may occur in more than 1 in 10 people)
Constipation
Diarrhea
Feeling of stomach fullness
Stomach pain
Discolored stools
Nausea

Uncommon (may occur in 1 in 100 people)
Throat swelling (laryngeal edema)
Unusual stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (irritation of the stomach)
Itching (pruritus)
Red skin rash (erythematous rash)

Frequency not known (cannot be estimated from available data)
Hypersensitivity reactions including anaphylactic reactions (severe, potentially life-threatening allergic reactions)
Angioedema (sudden swelling of the lips, cheeks, eyelids, tongue, soft palate, throat or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granuloma (inflammatory condition)*
Bronchial stenosis (narrowing of the airways)*
Esophageal ulceration*
Tooth discoloration**
Oral ulceration**
Esophageal changes*
Gastrointestinal melanosis (pigmentation in the gastrointestinal tract)***

*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of developing ulcers in the throat or esophagus (the tube connecting the mouth to the stomach). If a tablet enters the airways, there is a risk of bronchial ulceration, which may lead to bronchial stenosis.
**In cases of improper administration, when tablets are chewed, sucked, or held in the mouth.
*** Gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and received iron supplementation due to concomitant anemia.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tardyferon-Fol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Tardyferon-Fol contains

• The active substances are: iron(II) in the form of iron(II) sulfate, dried (iron(II) sulfate hydrate), and folic acid. One modified-release tablet contains 80 mg of iron(II) ions (as iron(II) sulfate, dried (iron(II) sulfate hydrate) – 247.25 mg) and 0.35 mg folic acid.
• Other components are:
  Tablet core: ammonio methacrylate copolymer (type A), ammonio methacrylate copolymer (type B), maltodextrin, triethyl citrate, talc, glyceryl dibehenate, microcrystalline cellulose
  Coating: titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172), triethyl citrate, Sepifilm LP 010 colorless: hypromellose, microcrystalline cellulose, stearic acid.

What Tardyferon-Fol looks like and contents of the pack
30 or 100 tablets in Al/PVC/PVDC blisters, packed in a cardboard box.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Pierre Fabre Medicament
45 place Abel Gance
92100 Boulogne-Billancourt
France
Manufacturer:
Pierre Fabre Medicament Production
Site Progipharm
Rue de Lycée, 45500 Gien
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Czech Republic, country of export: 12/135/92-S/C
Parallel import authorisation number: 109/17